Surgical retractor system and method

ABSTRACT

A retractor system is provided having a plurality of blade portions that collectively present a low profile tapered configuration for insertion through tissue along a natural tissue plane. Once inserted through tissue the blade portions may be independently moved apart to form an access path to a surgical site, such as by first moving the blade portions apart along the natural tissue plane followed by moving the blade portions apart transverse to the natural tissue plane. The blade portions may be attached to retractor frame members, and rack and pinion frame components may be used to control movement of the blade portions relative to one another. Pins may be used to secure the blade portions to bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of priority to U.S. Provisional PatentApplication Ser. No. 62/074,153 filed Nov. 3, 2014, which isincorporated by reference herein in its entirety.

BACKGROUND

Technical Field

The present disclosure relates to surgical retraction, and moreparticularly, to a minimally invasive retractor for spine surgery,including lateral access surgery.

Background of Related Art

In connection with surgery on the human spine, accessing the spine maybe difficult and complex, and traditional open access through manylayers of soft tissue contributes to post surgery pain and discomfort,and may prolong recovery and impede favorable results of surgery.

Attempts have been made to make retractors which provide less disruptiveaccess through soft tissue to reach the spine. Examples include HamadaU.S. Pat. Nos. 6,849,064; 7,318,817; 7,883,522; 7,935,054; 7,887,482 allentitled “Minimal Access Lumbar Diskectomy Instrumentation and Method”,and Hamada U.S. Pat. Nos. 7,850,608; 7,946,982; 8,636,657; 8,298,139;and 8,303,499 all entitled “Minimal Incision Maximal Access MIS SpineInstrumentation and Method”, all of which are incorporated herein byreference.

In so-called lateral access or trans-psoas muscle spine surgery thespine is approached from a lateral direction, from the side of thepatient. In this approach, access typically must be gained through thepsoas muscle in order to reach the spine. Retractors used for suchlateral access surgery include the Maximum Access Surgery (MAS®)platform from Nuvasive, Inc. (San Diego, Calif.), the MARS™3V systemfrom Globus Medical, Inc. (Audubon, Pa.), the Pipeline LS from DepuySynthes Spine (Raynam, Mass.) and the Direct Lateral Interbody Fusion(DLIF) system from Medtronic Sofamor Danek (Memphis, Tenn.). Thefollowing patents and published patent applications may show or describethese commercially available systems. Arambula U.S. Pat. No. 7,785,253entitled “Surgical Access System and Related Methods”; Wooley U.S. Pat.No. 8,535,320 entitled “Method and Apparatus for Performing SpinalSurgery”; Miles U.S. Published Patent Applications 2014/0180016 and2014/0288375, both entitled “Surgical Access System and RelatedMethods”; Pimenta U.S. Pat. No. 8,827,900 entitled “Surgical AccessSystem and Related Methods”; Frasier U.S. Pat. No. 8,550,995 entitled“Surgical Access Devices and Methods of Minimally Invasive Surgery”;Karpowicz U.S. Pat. No. 7,935,053 entitled “Surgical Retractor System”;and Weiman U.S. Pat. No. 8,353,826 entitled “Tissue Retractor and Methodof Use”. The foregoing patents and applications are incorporated hereinby reference.

The foregoing lateral access systems typically use a plurality ofsequentially dilating cannulas of increasing outer diameter inserted oneover another to create an initial access path to the spine. Once thelast dilating cannula is in place, a retractor assembly is inserted overthe dilating cannula, and is operated to move the retractor blades apartin a generally radial direction to spread soft tissue and create aworking path to the spine. Sequentially dilating cannulas, followed byradial retraction is not an efficient means to create a working path tothe spine, and spreading the soft tissue and the psoas muscle in thismanner is more traumatic to the tissue than necessary, and may prolongrecovery.

The Ravine® retractor system available from K2M, Inc. (Leesburg, Va.) isa substantial improvement in lateral spinal access retraction. TheRavine retractor system and method of use are described in Nunley U.S.Pat. No. 8,449,463 entitled “Lateral Access System and Methods of Use”,which is incorporated herein by reference. In the Ravine system, theretractor has two slim profile blades that are inserted through softtissue over a previously placed pin or wire with the retractor bladesaligned with the fibers of the psoas muscle. The retractor blades passbetween the fibers of the muscle with reduced trauma to the muscle, andwithout any need for sequentially dilating cannulas. Once the Ravineretractor is inserted, it is rotated ninety degrees to orient the bladestransverse to the psoas muscle. The retractor blades are then spreadapart to retract tissue and create a working path to the spine. Whilethe Ravine system is a significant improvement over other lateral accessretractors, a degree of trauma, albeit less than with other retractors,is introduced by rotating the retractor blades ninety degrees to splitthe psoas muscle, and then spreading the retractor blades apart.

Thus, a need exists for an improved retractor system to access the spinewith minimal trauma to soft tissue.

SUMMARY OF THE INVENTION

A retractor includes at least four retractor blades assuming a closedconfiguration having a low profile to facilitate insertion throughtissue along a natural tissue plane. The blades have an expandedconfiguration to retract tissue and provide access to a surgical site.

The retractor can include a frame or tool for controlling individualmovement of the blades toward and away from one another. The blades inthe closed configuration can define a substantially oblongcross-sectional profile to facilitate insertion through muscle fibers.The blades can define retractor quadrants that assume a closedconfiguration in which the cross-sectional configuration of theretractor has a first maximum dimension along one axis and a secondmaximum dimension along a second axis transverse to the first axis, thefirst dimension being greater than the second dimension.

Each quadrant blade can define a cross section having a substantiallystraight section along an internal edge in a first direction, asubstantially straight edge along a second internal surface in a seconddirection substantially perpendicular to the first direction, and anarcuate or oblique/tapered external edge connecting the externaltermination points of the internal edge and the straight edge. For eachcross section, an inner arcuate edge can connect the internal edge tothe straight edge. The arcuate edges of the blades can define alongitudinal through bore when the blade portions are in the closedconfiguration. The through bore can be configured and dimensioned toaccommodate a guide wire or guide pin.

A cam mechanism can be included in a distal tip of the retractor bladesin the closed configuration, wherein the cam mechanism is configured sorotation of a cam of the cam mechanism forces the blades apart. A cam ofthe cam mechanism can be positioned so rotation of the cam about a wireextending longitudinally through the blades forces the blades apart.

A method of performing surgery can include providing a surgicalretractor having at least four retractor blades assuming a closedconfiguration having a low profile to facilitate insertion throughtissue along a natural tissue plane, and an expanded configuration toretract tissue and provide access to a surgical site, the retractor inthe closed configuration having a length in a first direction that isgreater than the width of the retractor transverse to the length. Themethod includes inserting the retractor into tissue in the closedposition with the length in the first direction aligned with musclefibers of the tissue so as to insert the retractor in the closedconfiguration between tissue fibers until the tip of the retractorreaches a surgical site. The method also includes moving the bladesapart to divide the tissue fibers along the natural tissue plane of thetissue fibers and to retract tissue to form an access path to thesurgical site.

Moving the blades apart can include moving the blades apart along thenatural plane of muscle fibers to divide muscle tissue along the naturaltissue plane of a muscle, followed by the moving the blade portionsapart substantially perpendicular to the natural tissue plane of themuscle fibers. Moving the blades apart can include initially separatingthe blades using a cam mechanism in the proximate tip of the blades.Separating the blades using a cam mechanism can include rotating a camof the cam mechanism about a wire extending longitudinally through theblades. Moving the blades apart can include after initially separatingthe blades, using a tool to further separate the blades in along thenatural plane of muscle fibers.

Moving the blades apart can include using a tool to apply a distractingforce outward against the blades at the distal tip of the retractorblades. Moving the blades apart can include moving each bladeindependent of the other blades. Moving blades apart to divide tissuefibers can include first moving two pairs of the blades apart from oneanother along the first direction and then separating the blades in eachpair from one another in a direction transverse to the first directionto form the access path. The method can include inserting a pin though ahole in a respective one of the blades to anchor the respective blade tobone. It is also contemplated that the method can include mounting theblades to a frame at proximal ends of the blades.

These and other features of the systems and methods of the subjectdisclosure will become more readily apparent to those skilled in the artfrom the following detailed description of the preferred embodimentstaken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those skilled in the art to which the subject disclosureappertains will readily understand how to make and use the devices andmethods of the subject disclosure without undue experimentation,preferred embodiments thereof will be described in detail herein belowwith reference to certain figures, wherein:

FIG. 1a is a perspective view of an exemplary embodiment of a retractorblade assembly constructed in accordance with the present disclosure,showing the retractor blades in a closed configuration;

FIG. 1b is a perspective view of the assembly of FIG. 1, showing theblades in a retracted configuration for surgical access;

FIG. 2 is a cross-sectional end view of the blade assembly of FIG. 1,showing the cross sections of the individual blades;

FIGS. 3A-3D are transverse views of the assembly of FIG. 1, sowingstages in the use of the blade assembly to retract tissue for surgicalaccess to a spinal disc; and

FIGS. 4A-4B are schematic views, cross-sectional and perspective,respectively, showing a cam mechanism in the distal tip of the bladeassembly of FIG. 1 with the blades in the closed configuration; and

FIGS. 4C-4D are schematic views, cross-sectional and perspective,respectively, showing the cam mechanism in the distal tip of the bladeassembly of FIG. 1 with the blades after initial separation.

DETAILED DESCRIPTION

Reference will now be made to the drawings wherein like referencenumerals identify similar structural features or aspects of the subjectdisclosure. For purposes of explanation and illustration, and notlimitation, a partial view of an exemplary embodiment of a retractorblade assembly in accordance with the disclosure is shown in FIG. 1A andis designated generally by reference character 10. Other embodiments ofretractor blade assemblies in accordance with the disclosure, or aspectsthereof, are provided in FIGS. 1B-4D, as will be described. The systemsand methods described herein can be used to retract tissues, e.g., softtissues, for surgical access. The systems and methods disclosed hereinmay find application in any retraction situation where it is desirableto insert the retractor aligned the muscle fibers. One such applicationis a lateral, trans psoas approach to the spine. For convenience thesystems and methods disclosed herein are described in the exemplarycontext of trans psoas applications, but this disclosure is not limitedto this exemplary context.

Retractor blade assembly 10 includes four quadrant blades 12, 14, 16,18. Optionally, each quadrant blade may have a longitudinal through hole20, 22, 24, 26, respectively, and/or a groove on an inner edge thereofconfigured and dimensioned to receive a guide wire or pin therethrough.

Each quadrant blade 12, 14, 16, 18 defines a cross section, shown inFIG. 2, having a substantially straight section along a respectiveinternal edge 50, 52, 54, 56 in the first direction, e.g., the directionalong axis B-B. Each cross section also has a substantially straightedge 58, 60, 62, 64 along a respective second internal surface in asecond direction substantially perpendicular to the first direction,e.g., the direction along axis C-C. Each cross section also has anarcuate or oblique/tapered external edge 66, 68, 70, 74 along arespective external surface connecting the external termination pointsof the first and second surfaces corresponding to the respectiveinternal edges 50, 52, 54, 56, and the respective straight edges 58, 60,62, 64. A respective inner arcuate section or edge 76, 78, 80, 82connects each of the respective internal edges 50, 52, 54, 56 to arespective one of the straight edges 58, 60, 62, 64.

Alternatively or in addition, the center of the blade assembly 10 wherethe quadrant blades 12, 14, 16, 18 meet may be configured to define athrough passage 28 defined by inner arcuate edges 74, 76, 78, 80 forpassage of a guidewire or pin when the quadrant blades 12, 14, 16, 18are in the closed or approximated position shown in FIGS. 1a and 2. Eachquadrant blade 12, 14, 16, 18 is separate from the other quadrant bladesand is independently controlled to selectively spread apart in multipledirections. The movement of the quadrant blades 12, 14, 16, 18 iscontrolled by a frame structure 30 outside the body, such as a framehaving one or more rack and pinion arrangements to controllably move thequadrant blades apart from one another and maintain their relativeposition. It is contemplated that one or more rack and pinion framestructures, such as those described in Jako U.S. Pat. Nos. 5,503,617 and5,813,978 both entitled “Retractor and Method for Direct AccessEndoscopic Surgery”, both of which are incorporated herein by reference,the Hamada and Nunley patents referred to above may be adapted to permitindividual selective movement of each quadrant blade independent of theother quadrant blades.

With continued reference to FIG. 2, which is a cross-section view takenalong line A-A of FIG. 1, the cross-sectional configuration of the bladeshows that the quadrant blades 12, 14, 16, 18 collectively define a lowprofile configuration that is insertable through the psoas muscle withthe axis B-B aligned with the muscle fibers. In the closed configurationshown in FIGS. 1a and 2, the length of the retractor along axis B-B isgreater than the width of the retractor along axis C-C. The length ofthe retractor along axis B-B and the thickness of the blades along axisC-C are selected so that the blades in the closed position may beinserted between fibers of the psoas muscle without significant dilationand without inserting the retractor over previously inserted dilators.One or more dilators may be used to pre-dilate the space to receive theretractor, as contemplated in Nunley U.S. Pat. No. 8,449,463, but suchdilators are preferably used only to loosen the tissue to receive andaccept the retractor, but are removed prior to insertion of theretractor, such that the retractor is inserted directly into the muscleand not over such dilators. As previously discussed, the retractor maybe inserted over a pin or guidewire. In the closed position shown inFIGS. 1a and 2, retractor 10 has a maximum overall length along axis B-Bof about 40 mm and a maximum width along axis C-C of about 10 mm,however, any other suitable size can be used for a given application. Inaddition, the distal tip of the retractor is tapered, as shown, so thatthe tip and tapered sides of the retractor facilitate insertion of theretractor through muscle tissue in the closed position. The overalllength of the retractor quadrant blades 12, 14, 16, 18 is any suitablesize sufficient to reach the surgical site and extend out of the softtissue, and may range from about 1 cm to about 25 cm, for example.

Referring now to FIGS. 3A-3C, the insertion and function of theretractor assembly will now be described. In FIGS. 3A-3C, the retractorblades are shown relative to two adjacent vertebrae 40, 42, a spinaldisc 44 between the vertebrae and soft tissue and muscle to be dividedand retracted in order to provide access to the spine, particularly thespinal disc, for spine surgery. For convenience and by way of example,the use of the retractor is described in connection with a lateralsurgical approach to the spine through the psoas muscle. However, it iscontemplated that the retractor blade assembly may have application inother surgical settings.

As shown in FIG. 3A, the retractor blades are inserted through the psoasmuscle 32 with the blades in a closed, approximated configuration. Themuscle may be digitally or manually probed or otherwise dissected tofacilitate insertion of the retractor blades. Such dissection mayinvolve inserting one or more probes and/or distractors to loosen tissueand facilitate insertion of the retractor blades through the muscle.Optionally, a guide wire or pin may be placed into the disc or bone toguide the path of the retractor. In such case, the guidewire or pinwould be received through the openings 20, 22, 24, 26 or through thecenter 28 of the closed blades.

Once the retractor blades have been inserted to the desired depth, theblade portions may be spread apart in a controlled fashion to retracttissue and provide a working opening to the surgical site, with reducedtrauma to tissue. By way of example, in a preferred method shown inFIGS. 3A-3C, quadrant blades 12, 14 may be moved apart from quadrantblades 16, 18 along axis B-B, which is aligned with the direction of themuscle fibers to first divide the quadrant blades along the naturalplane of the muscle tissue. In this manner the muscle advantageously isdivided along the plane of muscle fibers. When the quadrant bladesoverlie desired portions of the vertebral bodies (see FIG. 3B), theblade pairs 12, 18 and 14, 16 may be separated along axis C-C, whichdefines a path substantially perpendicular to axis B-B, in order toretract tissue that has previously been divided along the plane of themuscle fibers to create and maintain an access path to the surgicalsite, illustrated as a spinal disc, as shown in FIG. 3C.

One or more quadrant blades may be secured to bone by inserting a pin29, shown in FIG. 1b , through the central opening 20, 22, 24, 26 of therespective quadrant blade 12, 14, 16, 18. Thus, for example, one or someor all of quadrant blades shown in FIG. 3C may be secured to bone andmaintained in position to maintain the positional relationship of thequadrant blades relative to each other and to the bone and, hence, thesurgical site. It is contemplated that the pins 29 used to anchor theblade or blades in place may have a threaded or possibly self-tappingthreaded tip. It is also contemplated that one or more pins 29 may beplaced before the quadrant blades are spread apart, or after thequadrants are partially spread apart, so as to provide controlledretraction and possibly to leverage retraction in a specific directionrelative to the pinned quadrant blade(s). In this regard, it may bedesirable to maintain the position of one quadrant relative to bonewhile spreading apart the other quadrant retractor blades, in order tooptimize the position of the quadrant retractor blades and, hence, theretracted soft tissue, relative to the surgical site. It is alsocontemplated that the shape of the tip portion of each retractorquadrant blade may be selected to conform to the shape of the underlyingbony structure, so that the retractor blade conforms to the bone surfaceand minimizes the possibility that tissue may work its way under theretractor blades into the operative area.

As will be appreciated, many variations of the blades and their use arepossible. In the broadest sense, the retractor consists of a number(preferably four) of blade portions which assume a closed positionconfiguration in which the blade portions in the aggregate present athin, low profile tapered blade retractor that is readily insertedthrough tissue along the natural plane of muscle tissue. Preferably, anydilation prior to insertion of the retractor is digital or with lowprofile probes and/or dilators, similar to those disclosed in NunleyU.S. Pat. No. 8,449,463. Advantageously, the blades may be insertedwithout dilating structure in place in the tissue. That is, theretractor need not be inserted over a distraction member or members, asis commonly the practice with many existing lateral access retractionsystems, where the retractor is inserted over previously inserteddilator(s).

It will also be understood that the quadrant blades may be spread apartin any desired orientation, order or sequence. Thus, blade pairs 12, 14and 16, 18 need not be spread apart longitudinally along axis B-B beforebeing spread apart transversely along axis C-C. Indeed, the quadrantblades may spread apart fully or partially in the transverse directionand then in the longitudinal, or any combination of partially expandingthe blades to gradually or sequentially reach full expansion. Moreover,the blade portions need not be moved in parallel. Rather, each bladeportion may be controlled and moved apart separate from the movement ofeach of the other blade portions so that the surgeon can optimallyretract tissue and orient and maintain the position of the retractor intissue relative to bone and the disc space.

Unlike the Ravine retractor, which must be rotated ninety degrees beforeseparating the blades, the present retractor does not need to be rotateninety degrees prior to separating the blades. The separation of theblade portions of the present retractor without rotating the retractorninety degrees provides greater control to the surgeon during retractionand reduces trauma to the tissue to be retracted. However, as shown inFIG. 3D, optionally the retractor quadrant blades can be rotated ninetydegrees relative to the muscle fibers to initiate separation along themuscle fibers, after which the blades can be rotated back to the initialposition for separation of the blades as shown in FIG. 3B.

In another exemplary embodiment, a method for use of a four bladedretractor includes placing a single tube guidewire cannula, confirmingthe guidewire position fluoroscopically, and placing the guidewire is inthe disk space, or other surgical site or target. Retractor blades,e.g., quadrant blades 12, 14, 16, 18, are placed over the guidewire as aunitary device consisting of two pairs of retractor blades. Each pair isinitially translated generally cephalad and caudad, e.g., as indicatedin FIG. 3B. Each pair of blades is then split to translate generallymedial and lateral, e.g., as indicated in FIG. 3C. Although thisscenario describes a rectangular surgical portal as an example, thoseskilled in the art will readily appreciate that the blades may be of anysuitable geometric configuration thereby resulting in any suitablenon-rectilinear retraction portal.

With reference now to FIGS. 4A-4D, the initial separating of cephaladand caudad blade pairs is important to provide working room for adistractor type tool that provides a distractor force at the distal end(anatomic target) of the blades. This initial separation can be providedby a rotating cam 34 that is designed to be part of the initial unitaryconfluence of all four retractor quadrant blades 12, 14, 16, 18, e.g, ina cavity formed between surfaces 36 and 38 in the distal end of passage28 (identified in FIG. 2). FIGS. 4A and 4B show cam 34 and thedistractor blades in their initial, unexpanded state. By rotation of cam34 about wire 31 extending longitudinally through the blades, theinitial distraction of quadrant blades 16 and 18 from quadrant blades 12and 14 can be accomplished, as shown in FIGS. 4C and 4D. A frangibleconnection can initially connect the blades together, which can bebroken during the initial separation. Those skilled in the art willreadily appreciate that cam 34 is exemplary, and that any other suitabletool can be used for the initial separation depicted in FIGS. 4A-4D.

After the initial separation illustrated in FIGS. 4A-4D, any othersuitable tool can be used that can provide mechanical separation ofquadrant blades 12, 14, 16, 18 in a number of different planes. Forinstance a tool may be designed with a single or double actionscissoring mechanism to separate either the blade pairs or individualblades. Another embodiment may be a mushroom base instrument activatedwith a screw type mechanism or an instrument such as a cannula over theguidewire with deployable mechanisms converting longitudinal translationdown the cannula to horizontal translation distracting the retractorblades.

Applying the distraction forces outward against quadrant blades 12, 14,16, 18 at the distal tip thereof, as opposed to at an external frame atthe proximal end thereof, reduces the amount of material strengthrequired for the quadrant blades 12, 14, 16, 18 relative to what wouldbe required if the forces were applied at the proximal end. This makesit possible to fabricate quadrant blades 12, 14, 16, 18 from disposablematerials such as polymers, and provides the potential advantages ofdisposability.

The blade pairs and individual blades are manipulated by one or multipledevices/tools that control the blade at its distal end (near theanatomic target) and so as to provide anatomic retraction andvisualization for the surgical procedure being performed. Once suitablypositioned each individual quadrant blade 12, 14, 16, 18 can be fixatedto the target tissue, e.g., bone or soft tissue. Each quadrant blade 12,14, 16, 18 can then now be fixated or locked into a proximal stationaryframe, e.g., frame 30 shown in FIG. 1b , or ring external to orimmediately at the wound or opening of surgical portal. In the exampledepicted in FIG. 1a , quadrant blades 12, 14, 16, 18 are attached to amultiply adjusted rectangular frame 30 allowing for complete freedom ofmovement (translation and rotation) of each individual quadrant blade12, 14, 16, 18. Additionally, although the quadrant blades 12, 14, 16,18 are shown and described as having a fixed length, blades may beallowed to have variable length by either a telescoping mechanism or amulti-segmental mechanism, or any other suitable mechanism, thusdecreasing need for extensive inventory with multiple sizes.

The methods and systems of the present disclosure, as described aboveand shown in the drawings, provide for surgical retraction with superiorproperties including reduced trauma and disposability. While theapparatus and methods of the subject disclosure have been shown anddescribed with reference to preferred embodiments, those skilled in theart will readily appreciate that changes and/or modifications may bemade thereto without departing from the scope of the subject disclosure.

What is claimed is:
 1. A retractor comprising: at least four retractorblades assuming a closed configuration having a low profile tofacilitate insertion through tissue along a natural tissue plane, and anexpanded configuration to retract tissue and provide access to asurgical site, further comprising a cam mechanism in a distal tip of theretractor blades in the closed configuration, wherein the cam mechanismis configured so rotation of a cam of the cam mechanism forces theblades apart, wherein the cam of the cam mechanism is positioned sorotation of the cam about an axis defined along a wire extendingparallel through the blades in a longitudinal direction of the bladesforces the blades apart, wherein the retractor blades include an innerledge that confines the cam from extending distally from the distal tipof the retractor blades in the closed configuration.
 2. The retractorrecited in claim 1, further comprising: a frame or tool for controllingindividual movement of the blades toward and away from one another. 3.The retractor as recited in claim 1, wherein the blades in the closedconfiguration define a substantially oblong cross-sectional profile tofacilitate insertion through muscle fibers.
 4. The retractor as recitedin claim 1, wherein the blades define retractor quadrants that assume aclosed configuration in which the cross-sectional configuration of theretractor has a first maximum dimension along one axis and a secondmaximum dimension along a second axis transverse to the first axis, thefirst dimension being greater than the second dimension.
 5. Theretractor as recited in claim 1, wherein each quadrant blade defines across section having a substantially straight section along an internaledge in a first direction, a substantially straight edge along a secondinternal surface in a second direction substantially perpendicular tothe first direction, and an arcuate or oblique/tapered external edgeconnecting the external termination points of the internal edge and thestraight edge.
 6. The retractor as recited in claim 5, furthercomprising: for each cross section an inner arcuate edge connecting theinternal edge to the straight edge.
 7. The retractor as recited in claim6, wherein the arcuate edges of the blades define a longitudinal throughbore when the blade portions are in the closed configuration.
 8. Theretractor as recited in claim 7, wherein the through bore is configuredand dimensioned to accommodate a guide wire or guide pin.